# US 11,298,162 B2 · Load sensing assembly for a spinal implant

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- Number: US 11,298,162 B2
- Document ID: US11298162B2
- Status: Granted
- Kind: B2
- Application number: 16/039,592
- Filed: 2018-07-19
- Published: 2020-01-23
- Granted: 2022-04-12
- Earliest claimed: 2018-07-19
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic, Inc.
- Inventors: Nicholas M. Benson; Richard L. Brown; Newton H. Metcalf; Clark B. Norgaard; Steven D. Glassman; Shane Burch; Domagoj Coric; Robert A Fields
- Web page: https://patentgrep.com/patent/US11298162B2

## CPC

- A61B 5/4851: {Prosthesis assessment or monitoring}
- A61B 17/7074: {Tools specially adapted for spinal fixation operations other than for bone removal or filler handling (A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39)}
- A61B 5/0008: {Temperature signals}
- A61B 5/0015: {characterised by features of the telemetry system}
- A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network}
- A61B 5/076: {Permanent implantation}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/4566: {Evaluating the spine (A61B5/4561 takes precedence)}
- A61B 5/6833: {Adhesive patches}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/6878: {Bone}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 17/7001: {Screws or hooks combined with longitudinal elements which do not contact vertebrae (A61B17/7058 takes precedence)}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7035: {Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other}
- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/02416: {using photoplethysmograph signals, e.g. generated by infrared radiation (A61B5/14552 takes precedence)}
- A61B 5/1126: {using a particular sensing technique}
- A61B 17/7041: {with single longitudinal rod offset laterally from single row of screws or hooks (A61B17/7044 takes precedence)}
- A61B 17/7044: {also having plates, staples or washers bearing on the vertebrae}
- A61B 17/705: {for linking adjacent ends of longitudinal elements}
- A61B 17/7055: {connected to sacrum, pelvis or skull}
- A61B 90/98: using electromagnetic means, e.g. transponders
- A61B 2017/00084: {Temperature}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/066: {for measuring torque}
- A61B 2560/0219: of externally powered implanted units
- A61B 2562/0252: Load cells
- A61B 2562/0261: Strain gauges
- A61B 2562/0271: Thermal or temperature sensors
- A61B 2562/046: in a matrix array
- A61B 2562/08: Sensors provided with means for identification, e.g. barcodes or memory chips
- A61B 2562/166: the sensor is mounted on a specially adapted printed circuit board
- A61F 2002/3067: {for data transfer}
- A61F 2002/4666: {for measuring force, pressure or mechanical tension}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A load sensing assembly for a spinal implant includes a set screw having a central opening that extends from a first end of the set screw toward a second end of the set screw. The second end of the set screw is configured to engage with an anchoring member. The load sensing assembly includes an antenna, an integrated circuit in communication with the antenna, where the integrated circuit is positioned within the central opening of the set screw, and a strain gauge in connection with the integrated circuit. The strain gauge is located within the central opening of the set screw in proximity to the second end of the set screw.

## Claims

### Claim 1

A load sensing assembly for a spinal implant, the load sensing assembly comprising:
a set screw extending in a longitudinal direction from a first end to a second end and having an outside surface comprising a thread pattern and an inside surface comprising a driving feature, the set screw further comprising a central opening that extends in the longitudinal direction from the first end of the set screw toward the second end of the set screw, wherein the thread pattern of the set screw is configured to engage with an anchoring member supporting a longitudinal rod;
an antenna positioned within the central opening;
an integrated circuit in communication with the antenna, wherein the integrated circuit is positioned within the central opening of the set screw; and
a strain gauge in connection with the integrated circuit, wherein the strain gauge is located within the central opening of the set screw in proximity to the second end of the set screw and is configured to measure a localized force between the second end of the set screw and the longitudinal rod when the second end contacts the longitudinal rod.

### Claim 2 (depends on 1)

The load sensing assembly of claim 1, wherein the set screw comprises a breakoff portion.

### Claim 3 (depends on 1)

The load sensing assembly of claim 1, further comprising an electronics component, wherein the electronics component comprises a top surface, a bottom surface, and one or more electrical circuits.

### Claim 4 (depends on 3)

The load sensing assembly of claim 3, wherein the integrated circuit is positioned on the top surface of the electronics component.

### Claim 5 (depends on 3)

The load sensing assembly of claim 3, wherein the strain gauge is operably connected to the bottom surface of the electronics component.

### Claim 6 (depends on 1)

The load sensing assembly of claim 1, wherein the integrated circuit comprises memory, wherein the integrated circuit is configured to:
store one or more measurements made by the strain gauge in the memory; and transmit the one or more measurements to a reader when the reader is in proximity to the integrated circuit.

### Claim 7 (depends on 1)

The load sensing assembly of claim 1, wherein the integrated circuit comprises memory, wherein the integrated circuit is configured to:
store a unique identifier associated with the set screw in the memory; and transmit the unique identifier to a reader when the reader is in proximity to the integrated circuit.

### Claim 8 (depends on 1)

The load sensing assembly of claim 1, further comprising an anchoring member comprising a channel that is configured to receive the longitudinal rod and a second strain gauge located within the channel, wherein the second strain gauge is configured to measure a localized force between the anchoring member and the longitudinal rod.

### Claim 9 (depends on 1)

The load sensing assembly of claim 1, wherein the integrated circuit comprises one or more of the following:
radio frequency identification (RFID) chip; or
near-field communication (NFC) chip.

### Claim 10 (depends on 1)

The load sensing assembly of claim 1, wherein the central opening comprises a circular opening defined by a consistent internal diameter.

### Claim 11

A load sensing assembly for a spinal implant, the load sensing assembly comprising:
a set screw extending in a longitudinal direction from a first end to a second end and having an outside surface comprising a thread pattern and an inside surface comprising a driving feature, the set screw further comprising a central opening that is coaxially aligned with the driving feature and extends in the longitudinal direction from the first end of the set screw to the second end of the set screw, wherein the thread pattern of the set screw is configured to engage with an anchoring member supporting a longitudinal rod while the second end of the set screw directly contacts the longitudinal rod;
an antenna;
an electronics component comprising one or more electrical circuits, wherein the electronics component is operably connected to the antenna;
an integrated circuit operably connected to at least a portion of the electronics component; and
a strain gauge in communication with the integrated circuit, wherein the strain gauge is located within the central opening of the set screw in proximity to the second end of the set screw and is configured to measure a localized force between the second end of the set screw and the longitudinal rod.

### Claim 12 (depends on 11)

The load sensing assembly of claim 11, wherein the electronics component is operably connected to the antenna via a connecting member having a longitudinal axis that extends in a perpendicular direction with respect to the antenna.

### Claim 13 (depends on 11)

The load sensing assembly of claim 11, wherein:
the antenna comprises a radio frequency identification coil,
the antenna is configured to circumferentially surround at least a portion of the set screw or a pedicle screw.

### Claim 14 (depends on 11)

The load sensing assembly of claim 11, wherein at least a portion of the antenna is positioned in a the central opening of the set screw.

### Claim 15 (depends on 11)

The load sensing assembly of claim 11, wherein the integrated circuit comprises memory, wherein the integrated circuit is configured to:
store one or more measurements made by the strain gauge in the memory; and transmit the one or more measurements to a reader when the reader is in proximity to the integrated circuit.

### Claim 16 (depends on 11)

The load sensing assembly of claim 11, wherein the integrated circuit comprises memory, wherein the integrated circuit is configured to:
store a unique identifier associated with the implant in the memory; and
transmit the unique identifier to a reader when the reader is in proximity to the integrated circuit.